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Monoclonal Antibodies

Ipi/Nivo + Sacituzumab Govitecan for Bladder Cancer

Boston, MA

Phase 1 & 2

Waitlist Available

Led By Jingsong K Zhang, MD

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years of age or older

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Must not have

Known history of HIV-1/2 with uncontrolled viral load and on medications that may interfere with SN-38 metabolism

Requires concomitant medication interfering with ABCA1 transporter or UGT1A1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new combination of drugs for people with metastatic bladder cancer.

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Who is the study for?

Adults with advanced bladder cancer who can't use cisplatin chemotherapy due to certain health issues. They must have a good performance status, no severe heart disease or active infections, and not be pregnant. Men and women must agree to contraception methods.Check my eligibility

What is being tested?

The trial tests Ipilimumab plus Nivolumab (IPI-NIVO) combined with Sacituzumab Govitecan in patients with metastatic bladder cancer. It aims to determine the effectiveness of this drug combination for those ineligible for cisplatin chemotherapy.See study design

What are the potential side effects?

Possible side effects include immune-related reactions affecting organs, infusion-related symptoms, fatigue, digestive problems like diarrhea or constipation, blood cell count changes increasing infection risk, and potential liver enzyme alterations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am fully active or can carry out light work.

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I cannot have cisplatin chemotherapy due to kidney, hearing, nerve issues, or heart problems.

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My cancer can be measured on scans and has grown in previously treated areas.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have HIV with a high viral load and take medication that could affect my treatment.

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I am taking medication that affects ABCA1 transporter or UGT1A1.

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I haven't taken high doses of steroids in the last 2 weeks, but may be on a stable low dose.

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I have a history of lung scarring or inflammation not caused by infections.

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I am not pregnant or breastfeeding.

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I do not have any ongoing heart problems.

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My cancer includes a small-cell component.

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I have previously been treated with sacituzumab govitecan, irinotecan, or a similar drug.

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I have had chemotherapy for bladder cancer that has spread.

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I have an ongoing inflammatory bowel condition or a history of bowel blockage.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase 1: Maximum Tolerated Dose

Phase 2: Overall Response Rate

Secondary study objectives

Phase 1: Duration of Response (DOR)

Phase 1: Overall Response Rate

Phase 1: Progression Free Survival (PFS)

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Phase 2: Treatment at Maximum Tolerated Dose (MTD)Experimental Treatment3 Interventions

Participants will be treated at with Ipilumumab 3mg/kg + Nivolumab 1mg/kg IV day 1 every 3 weeks for 4 cycles, followed by Nivolumab 360 mg every 3 weeks plus the maximum tolerated dose of Sacituzumab Govitecan days 1 and 8 every 3 weeks.

Group II: Phase 1 Dose Level 2Experimental Treatment3 Interventions

Participants will be treated at dose level 2: Ipilumumab 3mg/kg + Nivolumab 1mg/kg IV day 1 every 3 weeks for 4 cycles, followed by Nivolumab 360 mg every 3 weeks. Sacituzumab Govitecan 10 mg/kg IV will be administered days 1 and 8 every 3 weeks.

Group III: Phase 1 Dose Level 1Experimental Treatment3 Interventions

Participants will be treated at dose level 1: Ipilumumab 3mg/kg + Nivolumab 1mg/kg IV day 1 every 3 weeks for 4 cycles, followed by Nivolumab 360 mg every 3 weeks. Sacituzumab Govitecan 8 mg/kg IV will be administered days 1 and 8 every 3 weeks.

Group IV: Phase 1 Dose Level -1Experimental Treatment3 Interventions

If dose reduction is indicated, participants will be treated at dose level -1: Ipilumumab 3mg/kg + Nivolumab 1mg/kg IV day 1 every 3 weeks for 4 cycles, followed by Nivolumab 360 mg every 3 weeks. Sacituzumab Govitecan 6 mg/kg IV will be administered days 1 and 8 every 3 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ipilimumab

2015

Completed Phase 3

~3380

Nivolumab

2014

Completed Phase 3

~3880